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"We are excited to provide eye care professionals with a new and powerfultopical steroid," said Susan Benton, Senior Vice President of Sales andMarketing for Sirion Therapeutics, Inc. "Because Durezol is the first and onlysteroid with an approval for both inflammation and pain, it is the firstinnovation in the strong steroid class in over 35 years. We believe Durezolwill give patients and physicians a more comprehensive option forpostoperative care."
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Sirion Therapeutics has built a fully-staffed commercial infrastructurecomprised of a national specialty sales force that will promote Durezol, aMedical Science Liaison team that will communicate clinical information to themedical community, and a managed markets group that will secure access toDurezol through pharmacies and insurance plans.
Other marketing and product support initiatives in progress include anextensive sampling program, direct mail communications to physicians andpharmacists, the Durezol web site (www.durezol.com), telemarketing, areimbursement hotline, a patient-assistance program, and a customer supportnumber (1-866-4SIRION).
Durezol Phase 3b Studies
Sirion also announced today the completion of two Phase 3b studies thatevaluated Durezol for the management of postoperative inflammation in whichtreatment was initiated one day prior to surgery. The multicenter, randomized,double-masked, placebo-controlled, parallel-group trials were conducted in 245patients undergoing unilateral ocular surgery. In the first study of 124patients, Durezol or placebo was dosed 4 times daily (QID), while in thesecond study, 121 patients received Durezol or placebo twice daily (BID).
"The Phase 3b studies represent an approach to therapy that is mostsimilar to the current standard of care, meaning most physicians treatinflammation prophylactically rather than waiting for it to occur," explainedSteven Silverstein, M.D. of Silverstein Eye Centers. Dr. Silverstein was aprincipal investigator in the QID study and also serves as a clinicalassistant professor of ophthalmology at the University of Missouri-Kansas CitySchool of Medicine and the University of Health Sciences. "Overall, theresults from these studies show that by any definition utilized, Durezoladministered both BID and QID was more effective than placebo in treatingpostoperative ocular inflammation and relieving ocular pain/discomfort asearly as Day 3/4."
A significantly greater percentage of patients receiving Durezol QID orBID achieved a clinical response (defined as less than or equal to 5 anteriorchamber cells and no flare) by Day 14: 81.3% of the Durezol treated patientsin the QID group had a clinical response versus 25.0% of the placebo QID group(P < 0.0001); 74.7% of the Durezol BID patients had a clinical response versus42.5% of patients in the placebo BID group (P < 0.001). Both Durezol groupsmaintained superiority over the placebo groups through Day 28, demonstratingthat efficacy was definitive and did not decrease or reverse over time.
Ocular pain/discomfort was measured using the Visual Analogue Scale (VAS)score of 0-100 with 0 equal to no pain and 100 equal to maximal pain. Thepercentage of patients who were free of ocular pain/discomfort, reflected by aVAS score of 0, was superior and statistically significant for the Durezolgroups versus the placebo groups in both the QID and BID studies as early asDay 3/4 and throughout the study period.
Six percent of the Durezol QID patients and 3.7% of the Durezol BIDpatients experienced a criterion increase in intraocular pressure, defined asa pressure of greater than or equal to 21 mmHg and a change from baselinegreater than or equal to 10 mmHg at the same visit, compared with 0% in bothof the placebo groups.
"Durezol has shown efficacy across multiple endpoints, including painreduction. I believe it provides a potent new treatment option with afavorable safety profile," commented Dr. Silverstein. "It is a welcomeimprovement to the armamentarium of ocular pharmaceuticals, particularly sinceocular inflammation is common to the majority of conditions thatophthalmologists treat."
About Postoperative Inflammation
More than five million ophthalmic surgeries are performed each year in theUnited States. Postoperative inflammation and pain are common occurrencesfollowing these procedures and if left untreated, can interfere with apatient's visual rehabilitation or lead to further complications.Corticosteroids and non-steroidal anti-inflammatory drugs are commonly used byhealthcare professionals following ophthalmic surgery.
About Durezol
Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmiccorticosteroid for the treatment of inflammation and pain associated withocular surgery. Difluprednate, the active ingredient in Durezol, is adifluorinated derivative of prednisolone and has potent anti-inflammatoryactivity. Prior to U.S. approval, the efficacy and safety of difluprednate inocular inflammatory diseases had been demonstrated in an extensive preclinicaland clinical program in Japan. In two U.S. Phase 3 trials evaluating Durezolin patients diagnosed with significant postoperative inflammation (more than10 anterior chamber cells), Durezol effectively reduced inflammation and pain.Mean intraocular pressure for all study groups remained within the normalrange throughout the study. Durezol is being studied in other ocularinflammatory diseases, including a U.S. Phase 3 study evaluating Durezol forthe treatment of anterior uveitis.
Dosage and Administration
The recommended dosage and administration of Durezol is to instill onedrop into the conjunctival sac of the affected eye(s) 4 times daily beginning24 hours after surgery and then continue throughout the first 2 weeks of thepostoperative period, followed by 2 times daily for a week with tapering basedon the response.
Important Safety Information
Durezol, like other corticosteroids, is contraindicated in patients withviral diseases of the cornea and conjunctiva, and also in fungal infections ormycobacterial infections of the eye or ocular structures. Prolonged use ofcorticosteroids may increase the hazard of secondary ocular infections,exacerbate the severity of ocular viral infections, and increase thedevelopment of fungal infections of the cornea. It is important to monitorintraocular pressure when using ophthalmic steroids. The use of steroids aftercataract surgery may delay healing and increase the incidence of blebformation.
Adverse reactions associated with ophthalmic steroids include elevatedintraocular pressure, which may be associated with optic nerve damage, visualacuity and field defects, posterior subcapsular cataract formation, secondaryocular infection from pathogens including herpes simplex, and perforation ofthe globe where there is thinning of the cornea or sclera.
Ocular adverse reactions occurring in 5-15% of subjects in clinicalstudies with Durezol included corneal edema, ciliary and conjunctivalhyperemia, eye pain, photophobia, posterior capsule opacification, anteriorchamber cells, anterior chamber flare, conjunctival edema, and blepharitis.Other ocular adverse reactions occurring in 1-5% of patients included reducedvisual acuity, punctate keratitis, eye inflammation, and iritis. Ocularadverse events occurring in < 1% of patients included application sitediscomfort or irritation, corneal pigmentation and striae, episcleritis, eyepruritis, eyelid irritation and crusting, foreign body sensation, increasedlacrimation, macular edema, scleral hyperemia, and uveitis. Most of theseevents may have been the consequence of the surgical procedure.
About Sirion Therapeutics, Inc.
Sirion Therapeutics is a privately held biopharmaceutical company pursuingthe discovery, development, and commercialization of products addressing unmetmedical needs in the protection and preservation of eyesight. Sirion's diverseproduct portfolio includes products that address ocular diseases andconditions including uveitis, herpetic keratitis, dry eye, and geographicatrophy associated with dry AMD. For more information, please visitwww.siriontherapeutics.com.To view the Multimedia News Release, go to:http://www.prnewswire.com/mnr/durezol/34934/
SOURCE Sirion Therapeutics, Inc.
